If your digital health product is going live in the NHS, you need a clinical safety case. I'm a practising NHS doctor and a contracted CSO. Fixed scope, fixed fee, no surprises, no theatre.
DCB 0129 (manufacturer) and DCB 0160 (deploying organisation) are mandatory under the Health and Social Care Act 2012 for any health IT system used by the NHS. No clinical safety case, no DTAC pass, no procurement, no live deployment.
Most early-stage teams underestimate this. The cost is not the consultancy fee — it's the slipped go-live and the cancelled trust pilot. I exist to keep that timeline intact.
New to this? Read DCB 0129 explained in plain English for the full picture first.
Included:
Not included: DTAC / DSPT cross-walks and post-launch work.
One-off, fixed fee. Four-week turnaround.Included:
Not included: work beyond the included hours — billed at £180/hr.
Required while I am your named CSO. Monthly, cancel any time.Included:
If your deploying organisation's clinical safety review rejects the CSCR, revisions are free until it's accepted.
DigitalHealth.London, NHS Innovation Accelerator, university incubators and similar — mention your programme when you get in touch for partner pricing.
Everything in the £8,500 fixed-fee package — a complete clinical safety case, ready to submit to your deploying NHS organisation, with a CSO signature on the line. And what continues after go-live.
DCB 0129-conformant CSCR: intended use, scope, safety claims, hazard summary and residual risk justification. Written in language a clinical safety committee will accept first time.
~10-page reportFull CRMF with hazard identification workshop, risk evaluation matrix, mitigation traceability, and pre/post-mitigation risk scores. Maintained as a live document.
~30 hazards typicalEngineering-actionable safety requirements, mapped to your hazards. Your dev team gets a clear backlog; your auditor gets traceability.
JIRA / Linear-readySigned CSO release memo confirming residual risk acceptability — the document your deploying trust actually wants to see before they switch you on.
Signed by CSOThe PMS plan document — incident review process, trigger thresholds and reporting cadence. Required by DCB 0129 and DTAC before go-live. Running the surveillance itself happens post go-live, under the retainer.
Plan included · execution under retainerI can remain your named CSO after go-live under the monthly retainer — hazard log custody, quarterly PMS reviews, incident availability. DTAC and DSPT cross-walks and other ad-hoc work are hourly.
£750 / mo retainer · £180 / hr90-minute kickoff. I learn your product, your users, your deployment context. You get a draft scope and a fixed quote within 48 hours.
Half-day workshop with your clinical and engineering leads. We work through the hazard log together. By the end you have a populated CRMF.
I write the CSCR, safety requirements and PMS plan. You stay heads-down on shipping. One short check-in mid-week.
Final review, residual risk acceptance, signed release memo. Package handed over in a Git-tracked folder, ready for DTAC and trust submission.
A registered clinician, trained in clinical risk management, who is accountable for the clinical safety of a health IT system. DCB 0129 and 0160 require a named CSO to review and sign off the clinical safety case before NHS go-live. I'm a practising NHS doctor and contracted CSO based in England.
If your product is health IT used by the NHS — yes, it's mandatory under the Health and Social Care Act 2012. No safety case means no DTAC pass, no procurement, no go-live. New to the standard? Read DCB 0129 explained in plain English.
Four weeks from kickoff to signed release memo, if your team shows up to one kickoff and one half-day hazard workshop. The package is fixed-scope and fixed-fee, so the timeline doesn't drift.
If I remain your named CSO, that's the retainer: £750/month covering hazard log custody, quarterly post-market surveillance review, incident availability and 2 hours of work. Anything beyond that — and one-off work without a retainer — is £180/hr, logged transparently and billed monthly.
Send me the product, the timeline and the trust you're deploying into. I'll reply within 24 hours with a yes, a no, or a referral.